MACROGOLS SOP
1.0 OBJECTIVE:
To
lay down a procedure of analytical report for the active raw material of the Macrogols from the
Pharmacopoeial specifications.
2.0 SCOPE:
This
SOP shall be applicable in Q.C laboratory.
3.0 RESPONSIBILITY:
3.1
Q.C Analysts.
4.0 ACCOUNTABILITY:
4.1
Q.C Manager.
5.0 PROCEDURE:
5.1 Characters:
5.1.1
Appearance:
5.1.1.1
White or almost
white solid with a waxy or paraffin-like appearance.
5.1.2
Solubility:
5.1.2.1
Material and equipment:
5.1.2.1.1
Glassware (5 test
tubes, 1 spatula, 1 pipette).
5.1.2.1.2
alcohol
5.1.2.1.3
Methylene chloride.
5.1.2.1.4
Fatty oils.
5.1.2.1.5
Mineral oils.
5.1.2.1.6
Purified water.
5.1.2.2
Sample:
5.1.2.2.1
Small quantity.
5.1.2.3
Method:
5.1.2.3.1
Take 5 test tubes
and add small quantity of sample for testing solubility according to B.P
specifications.
5.1.2.3.2
Add purified water
in test tube 1 and observe.
5.1.2.3.3
Add methylene chloride
in test tube 2 and observe.
5.1.2.3.4
Add alcohol in
test tube 3 and observe.
5.1.2.3.5
Add fatty oil in
test tube 4 and observe.
5.1.2.3.6
Add mineral oil in
test tube 5 and observe.
5.1.2.4
Observations:
5.1.2.4.1
The sample in test
tube 1 & 2 containing with purified water & methylene chloride is very
soluble, respectively.
5.1.2.4.2
The sample in test
tube 3 containing with alcohol is very slightly soluble.
5.1.2.4.3
The sample in test
tube 4 & 5 containing with fatty oils and mineral oils are practically insoluble.
5.2 Identification
tests:
5.2.1
5.2.1.1
Material and equipment:
5.2.1.1.1
Glassware (1
stoppered test tube, 1 spatula).
5.2.1.1.2
0.5ml of sulfuric
acid.
5.2.1.1.3
1.0ml of mercuric
chloride solution.
5.2.1.2
Sample:
5.2.1.2.1
1.0g.
5.2.1.3
Method:
5.2.1.3.1
Take a test tube
and add 1.0g of sample in it.
5.2.1.3.2
Add 0.5ml of
sulfuric acid, close the test tube with a stopper fitted with a bent delivery
tube.
5.2.1.3.3
Heat it on Bunsen
burner until fumes are evolved.
5.2.1.3.4
Collect the fumes
via the delivery tube into another test tube containing with 1.0ml of mercuric
chloride solution R.
5.2.1.3.5
Observe the
changes.
5.2.1.4
Observations:
5.2.1.4.1
An abundant,
white, crystalline ppt is formed.
5.2.2
5.2.2.1
Material and equipment:
5.2.2.1.1
Glassware (1
stoppered test tube, 1 spatula).
5.2.2.1.2
0.1g of potassium
thiocyanate.
5.2.2.1.3
0.1g of cobalt
nitrate.
5.2.2.1.4
5.0ml of methylene
chloride.
5.2.2.2
Sample:
5.2.2.2.1
0.1g.
5.2.2.3
Method:
5.2.2.3.1
Take a test tube
and add 0.1g of sample in it.
5.2.2.3.2
Add 0.1g of
potassium thiocyanate and 0.1g of cobalt nitrate. Mix it thoroughly by using
glass rod.
5.2.2.3.3
Add 5.0ml of
methylene chloride and shake.
5.2.2.3.4
Observe the
changes.
5.2.2.4
Observations:
5.2.2.4.1
The liquid phase
becomes blue.
6.0 REVISION LOG:
|
Revision No.
|
Effective Date
|
Reason
|
|
00
|
|
New SOP
|
7.0 REFERENCES:
7.1
The British
Pharmacopoeia. Vol II.,
Official Monograph / Macrogols: 2015, pp. 146-149.
8.0 ANNEXURES:
8.1
Not Applicable.
9.0 ABBREVIATIONS:
|
Abbreviation
|
Expanded Form
|
|
SOP
|
Standard
operating procedure
|
|
&
|
And
|
|
No.
|
Number
|
|
Ltd.
|
Limited
|
|
Q.C
|
Quality
control
|
|
B.P
|
British
pharmacopoeia
|
|
mg
|
Milligram
|
|
ml
|
Milliliter
|
|
g
|
Grams
|
|
Vol
|
Volume
|
|
QCA
|
Quality
control active ingredient
|
|
F
|
Format
|
|
%
|
Percentage
|
|
B.P
|
British
pharmacopoeia
|
|
ppt
|
Precipitates
|